Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)

Gynecologic Disease Clinical Trial

— antiadhesion  

Official title:

Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03007654
• Other study ID #: CG-AHS008
• Status: Recruiting
• Phase: Phase 3
• First received: December 30, 2016
• Last updated: January 3, 2017
• Start date: December 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2017
• Source: Seoul National University Hospital
• Contact: Yongsang Song, MD
• Phone: +82-10-9580-1023
• Email: yssong[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients with Gynecological disease (benign disease)

• Patients who Written informed consent

• Patients without clinically significant lab

Exclusion Criteria:

• having enrolled another clinical trials within 1 month

• Immunosuppression or autoimmune disease

• Anticoagulant, general steroids within a week from surgery

• Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

• Patients with previous history of surgery at the same operate site

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease

Intervention

Device:
• Mediclore
apply medical device fully around intrauterine surgery area
• Adept
apply medical device fully around intrauterine surgery area

Locations

Country	Name	City	State
Korea, Republic of	Seoutl National University Hospital	Seoul City

Sponsors (1)

Lead Sponsor	Collaborator
Yong Sang Song

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adhesion rate	4 weeks after surgery, finding adhesion using visceral slide test	4 weeks after surgery	No
Secondary	Incidence of adhesion symptoms	4 weeks after surgery, Identifying adhesion sysmptoms using Questionnaire	4 weeks after surgery	No
Secondary	adverse event	identifying adverse events after surgery	4 weeks after surgery	Yes